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Trial record 1 of 1 for:    NCT00314054
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Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults

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ClinicalTrials.gov Identifier: NCT00314054
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : April 14, 2008
Sponsor:
Collaborator:
ViroPharma
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE April 10, 2006
First Posted Date  ICMJE April 12, 2006
Last Update Posted Date April 14, 2008
Study Start Date  ICMJE May 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
To assess PK in subjects with chronic hepatic impairment and in matched healthy adults [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2006)
To assess PK in subjects with chronic hepatic impairment and in matched healthy adults.
Change History Complete list of historical versions of study NCT00314054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults [ Time Frame: 15 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2006)
To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
Official Title  ICMJE An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of HCV-796 in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults
Brief Summary The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with chronic hepatic impairment and in matched healthy adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C
  • Hepatic Insufficiency
Intervention  ICMJE Drug: HCV-796
HCV-796 1000mg single dose
Study Arms  ICMJE Experimental: 1
HCV-796 1000mg single dose
Intervention: Drug: HCV-796
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 11, 2006)
27
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women of non-childbearing potential.
  • Hepatic impairment subjects: Child-Pugh class A, B, or C according to the C-P classification based on history, physical examination, and laboratory test results.
  • Healthy volunteers: healthy as determined by the investigator.

Exclusion Criteria:

  • History of alcoholism within 1 year.
  • Hepatic impairment subjects: evidence of unstable clinically significant disease other than impaired hepatic function.
  • Healthy volunteers: positive serologic findings for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00314054
Other Study ID Numbers  ICMJE 3173A1-105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE ViroPharma
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP